CN101721444B - Saussurea involucrate self-micro-emulsion, preparation method thereof and application thereof - Google Patents
Saussurea involucrate self-micro-emulsion, preparation method thereof and application thereof Download PDFInfo
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- CN101721444B CN101721444B CN2009101135363A CN200910113536A CN101721444B CN 101721444 B CN101721444 B CN 101721444B CN 2009101135363 A CN2009101135363 A CN 2009101135363A CN 200910113536 A CN200910113536 A CN 200910113536A CN 101721444 B CN101721444 B CN 101721444B
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Abstract
The invention discloses a saussurea involucrate self-micro-emulsion and a preparation method thereof and application thereof. The method for preparing the saussurea involucrate self-micro-emulsion mainly comprises the following steps: dissolving saussurea involucrate extractives in an assistant emulsifier; adding the emulsifier in an oil phase; mixing the solution of the saussurea involucrate and the oil phase with high-speed stirring; and adding the distilled water in the mixture to form the relatively stable self-micro-emulsion. The self-micro-emulsion of the invention comprises the oil phase, a surfactant and an assistant surfactant, and is dispersed to form nano-scale micro-emulsion grains in the presence of water or gastrointestinal fluids under the action of the physiological temperature and gastrointestinal peristalsis after being taken, so the self-micro-emulsion can be widely applied to various preparations for oral use, such as oral liquids, tablets and capsules, and also can be applied to injections, lotions, embrocations, patches or electuaries.
Description
Technical field:
The present invention relates to a kind of about the Saussurea involucrate self-micro-emulsion preparation.
Background technology:
Herba Saussureae Involueratae (Saussurea) is a Compositae phoenix hair Chrysanthemum plant, and the master uses its dry aerial parts, and summer, autumn gathered, dry in the shade subsequent use when two seasons, the flowers are in blossom.The chemical constituent of Herba Saussureae Involueratae mainly contains: flavone compound, saccharide, alkaloid, terpenoid and derivant thereof etc.Main pharmacological is anti-inflammatory and antalgic, spasmolytic, blood pressure lowering and relieving asthma and aspect such as enhancing human body immunity power.Pharmacopoeia of People's Republic of China little hardship of version record Herba Saussureae Involueratae, warm in nature in 2005.Its function cures mainly and is invigorating kidney, promoting blood circulation, bone and muscle strengthening, trophic nerve, dysregulation body fluid.Be used for rheumatic arthritis, arthralgia, lung cold cough, kidney and cold and pain in the lower abdomen, leukorrhagia etc.
Xinjiang Tianshan Herba Saussureae Involueratae Saussurea involucrate (Kar.et Kir.) Sch.Bip. main product is from surrounding area, the more rich Mountain Ranges of Tian Shan Mountains of sunlight illumination; Owing to absorb be bestowed by heaven sunlight, Tianshan Mountains snow water; Get natural essence China, it is extremely excellent to bring up " Herba Saussureae Involueratae " quality, and flavonoids effective constituent content is higher relatively; Be the rare Chinese medicine of China, abundant medical value is arranged.
But present Herba Saussureae Involueratae goods seldom, and are among the people with all herbal medicine, mainly obtain wherein effective ingredient through infusion, the mode of steeping in wine; Obtain difficulty; The mode of taking is single, can not long-rangely carry, and is difficult to the popularization of scale property; And can not targetedly effective ingredient be used as medicine, its absorption efficiency can not guarantee.
Along with the development of the modernization of Chinese medicine, the useful effect composition is extracted out through advanced person's instrument and equipment in the Chinese medicine, and the dosage form of medicine is also in continuous increase, for medicine in the intravital absorption of machine with play a role to provide more widely and select.
In recent years the Herba Saussureae Involueratae injection that occurs has better solved the utilization of effective ingredient and has been beneficial to the problem of absorption of human body, but because using of its preparation needs certain condition, inconvenience is carried, and has influenced widely to apply.
Research shows, some good water solubility and the relatively poor medicine of mucosa permeability are processed and can be improved mucosa behind the w/o microemulsion and see through ability, improve the intestinal absorption of medicine.Good according to the dissolubility of Herba Saussureae Involueratae extract in water, all can not fine dissolved character in some oil phases commonly used, select for use microemulsion as the medicine carrying form, development Saussurea involucrate self-micro-emulsion preparation has also been done investigation to its stability simultaneously.
Good according to the dissolubility of Herba Saussureae Involueratae extract in water; All can not fine dissolved character in some oil phases commonly used; Select for use microemulsion as the medicine carrying form,, active constituent content easy to carry and use for further exploitation and the high Herba Saussureae Involueratae oral products of absorbance just become possibility.
Summary of the invention:
The object of the invention is just in order to improve and to solve the problem that exists in the above-mentioned Herba Saussureae Involueratae drug absorption and a kind of method for preparing and application thereof with Saussurea involucrate self-micro-emulsion preparation of the distinct effect of absorption of improving and promoting the Herba Saussureae Involueratae medicine is provided.
The method for preparing of Saussurea involucrate self-micro-emulsion preparation of the present invention mainly may further comprise the steps:
Quantitatively get ethanol, 1, one or more of 2-propylene glycol, ethylene glycol are as co-emulsifier, and by adding Herba Saussureae Involueratae extract 0.1 weight portion in the 100 weight portion co-emulsifier to excessive, 3～45min ultrasonic dissolution gets Herba Saussureae Involueratae solution under 20～50 ℃ of conditions;
With soybean oil, Oleum Ricini, ethyl oleate, isopropyl myristate arbitrarily one or more as oil phase; 1～20 weight portion is got as emulsifying agent with Tween 80 with the arbitrary proportion mixing by the class of department 80; Join in 5～100 weight portion oil phases 1000～8000rpm mixing and stirring;
Said Herba Saussureae Involueratae solution and the oil phase mixed high-speed stirred under 1000～8000rpm by 1: 10～1: 100 evenly is placed in 20～40 ℃ of waters bath with thermostatic control, continues under 100～2500rpm stirring condition, slowly to add distilled water; During first the interpolation, mixed solution presents muddiness, adds to when a certain amount of; The solution becomes clarification forms self-micro emulsion formulation of the present invention, when continuing to add; When obvious light blue opalescence occurring, can stop to add, it is the boundary that the distilled water interpolation upper limit begins muddiness with solution; As muddiness appears, the supernatant of getting after the clarification is self-micro emulsion formulation of the present invention.
Above-mentioned Herba Saussureae Involueratae extract is at least a in Herba Saussureae Involueratae injection, Herba Saussureae Involueratae injection intermediate, Herba Saussureae Involueratae water extract or the ethanol extract.
Above-mentioned oil phase preferred oil acetoacetic ester or isopropyl myristate are as oil phase.
Saussurea involucrate self-micro-emulsion preparation of the present invention can be applied in the various preparations, can process in oral liquid, tablet, capsule, injection, lotion, liniment, patch or the electuary by corresponding rules.
Saussurea involucrate self-micro-emulsion preparation of the present invention is made up of oil phase, surfactant and cosurfactant; Take the back under physiology body temperature, gastrointestinal motility effect; Meet water or gastro-intestinal Fluid and be dispersed into the nano level microemulsion granule of particle diameter below 400nm, be very beneficial for absorption by human body, thereby can be applied in the various oral formulations; As process oral liquid, tablet, capsule, also can be applicable in injection, lotion, liniment, patch or the electuary.
The specific embodiment:
Embodiment 1:
In the ethanol with the excessive adding 90% of Herba Saussureae Involueratae ethanol extract,, get supernatant as Herba Saussureae Involueratae solution at 25 ℃ of following ultrasonic 30min of temperature; Getting department class 80 and Tween 80 is to mix at 10: 7 as composite emulsifier 1 weight portion and 5 ethyl oleate as oil phase with weight ratio; Take by weighing 1 weight portion Herba Saussureae Involueratae solution and under the 1200rpm high-speed stirred, join in the 50 weight portion oil phases, continue under the 1200rpm stirring condition, slowly to add distilled water,, stop to add, promptly obtain self-micro emulsion formulation of the present invention when adding the solution becomes clarification to.
Embodiment 2:
By per 100 weight portions 1, the 2-propylene glycol dissolves in the ratio of 1 weight portion Herba Saussureae Involueratae water extract, and 200000Hz ultrasonic dissolution 10min gets Herba Saussureae Involueratae solution under 45 ℃ of conditions; As oil phase, 10 weight portions are got as emulsifying agent with Tween 80 with 1: 1 mixed with isopropyl myristate by the class of department 80, join in the 100 weight portion oil phases, 15000rpm mixes stirring 3min; Said Herba Saussureae Involueratae solution and oil phase stirred by 10: 100 part by weight mixing 1500rpm be placed in 30 ℃ of waters bath with thermostatic control; Continue under the 1500rpm stirring condition, slowly to add distilled water, when obvious light blue opalescence occurring; Stop to add, promptly obtain self-micro emulsion formulation of the present invention.
Embodiment 3:
At the excessive adding of ethylene glycol Herba Saussureae Involueratae water extract, 100000Hz ultrasonic dissolution 15min under 35 ℃ of conditions leaves standstill and gets supernatant to layering and get Herba Saussureae Involueratae solution; Mix as oil phase by 2: 1 weight ratio with soybean oil and Oleum Ricini, will take charge of class 80 and Tween 80 get 5 weight portions as emulsifying agent after with 3: 1 weight ratio mixing, join in the 100 weight portion oil phases 6000rpm mixing and stirring; Said Herba Saussureae Involueratae solution and oil phase be blended in to stir under the 500rpm by 1: 100 weight ratio be placed in 25 ℃ of waters bath with thermostatic control; Continue under the 1000rpm stirring condition; Slowly add distilled water; Mixed solution presents muddiness-clarification, promptly stops to add when occurring muddiness once more, and the supernatant of getting after the clarification is self-micro emulsion formulation of the present invention.
Embodiment 4:
Add the ratio of 2 weight portion Herba Saussureae Involueratae injection intermediate in per 100 weight portion ethylene glycol, 150000Hz ultrasonic dissolution 5min gets Herba Saussureae Involueratae solution under 30 ℃ of conditions; , as oil phase class 80 of 10 weight portion departments as emulsifying agent, is joined in the 100 weight portion oil phases with 3: 1 blended Oleum Ricini of weight ratio and ethyl oleate, mix with 7200rpm; Said Herba Saussureae Involueratae solution and oil phase mixed in 10: 100 ratio 1000rpm be placed under 20～40 ℃ of constant temperature; Continue under the 2000rpm stirring condition; Slowly add distilled water; When mixed solution presents obvious light blue opalescence, promptly stop to add, gained liquid is self-micro emulsion formulation of the present invention.
Embodiment 5:
Excessive adding Herba Saussureae Involueratae ethanol extract in ethanol, 50000Hz ultrasonic dissolution 15min under 38 ℃ of conditions leaves standstill to clarify and gets supernatant to layering and get Herba Saussureae Involueratae solution; With the ethyl oleate is oil phase, and 5 weight portions are got as emulsifying agent with Tween 80 with 1: 4 part by weight mixing by the class of department 80, joins in the 100 weight portion oil phases 5000rpm mixing and stirring; Said Herba Saussureae Involueratae solution and oil phase stirred by 3: 100 part by weight mixing 300rpm be placed in 20～40 ℃ of waters bath with thermostatic control; Continue under the 500rpm stirring condition; Slowly add distilled water; When mixed solution presents obvious light blue opalescence, promptly stop to add, gained liquid is self-micro emulsion formulation of the present invention.
Embodiment 6:
Get that the Herba Saussureae Involueratae water extract is excessive to be dissolved in 1: 1 volume ratio blendedly 1, as co-emulsifier, 20min ultrasonic dissolution under 30 ℃ of conditions leaves standstill clarification to obviously layering, gets supernatant and gets Herba Saussureae Involueratae solution in 2-propylene glycol and the ethylene glycol mixture; As oil phase, the class of department 80 and Tween 80 amalgam 20 weight portions that with weight ratio are 1: 2 mixed join in the 100 weight portion oil phases as emulsifying agent with isopropyl myristate, and 8000rpm mixes; Above-mentioned Herba Saussureae Involueratae solution and oil phase are stirred 30min by 5: 100 mixed 8000rpm to be placed in 30 ℃ of waters bath with thermostatic control; Continue under the 1000rpm stirring condition, slowly to add distilled water, when obvious light blue opalescence occurring; Promptly stop to add, gained liquid is self-micro emulsion formulation of the present invention.
Embodiment 7:
Get the Herba Saussureae Involueratae water extract and ethanol extract is excessive is dissolved in 1: 1 volume ratio blended 1 by 1: 1 weight ratio; In 2-propylene glycol, ethanol, the ethylene glycol mixture as co-emulsifier; 25min ultrasonic dissolution under 28 ℃ of conditions leaves standstill clarification to obviously layering, gets supernatant and gets Herba Saussureae Involueratae solution; As oil phase, the class of department 80 and Tween 80 amalgam 8 weight portions that with weight ratio are 1: 1 mixed join in the 100 weight portion oil phases as emulsifying agent with ethyl oleate, and 5000rpm mixes; Above-mentioned Herba Saussureae Involueratae solution and oil phase are stirred 30min by 10: 100 mixed 5000rpm to be placed in 30 ℃ of waters bath with thermostatic control; Continue under the 800rpm stirring condition, slowly to add distilled water, when obvious light blue opalescence occurring; Promptly stop to add, gained liquid is self-micro emulsion formulation of the present invention.
Embodiment 8:
Get the Herba Saussureae Involueratae water extract and ethanol extract is excessive is dissolved in 1: 1: 1 volume ratio blended 1 by 1: 1 weight ratio; In 2-propylene glycol and the alcohol mixeding liquid as co-emulsifier; 20min ultrasonic dissolution under 35 ℃ of conditions leaves standstill clarification to obviously layering, gets supernatant and gets Herba Saussureae Involueratae solution; With the ethyl oleate of 1: 1 weight proportion and isopropyl myristate amalgam as oil phase; The class of department 80 and Tween 80 amalgam 5 weight portions that with weight ratio are 3: 2 mixed are as emulsifying agent; Join in the 100 weight portion oil phases, 6000rpm mixes; Above-mentioned Herba Saussureae Involueratae solution and oil phase are stirred 30min by 8: 100 mixed 4000rpm to be placed in 30 ℃ of waters bath with thermostatic control; Continue under the 600rpm stirring condition, slowly to add distilled water, when obvious light blue opalescence occurring; Promptly stop to add, gained liquid is self-micro emulsion formulation of the present invention.
Embodiment 9:
Claim 1～8 is made Saussurea involucrate self-micro-emulsion preparation 65 weight portions of a said method preparation; Add blending tank, add soft capsule matrix 500 weight portions, natural flavorant is an amount of, by the requirement of soft capsule preparation; Remove impurity; Antibacterial requires to carry out soft capsule preparation according to hygienic requirement condition and trimmed size, processes the Saussurea involucrate self-micro-emulsion soft capsule prepn
Embodiment 10:
Claim 1～8 is made Saussurea involucrate self-micro-emulsion preparation 1 weight portion of a said method preparation; Add blending tank, add injection substrate 5 weight portions, by the full and uniform mixing of injection preparation requirement; Filtering and impurity removing; Radiation sterilizing requires to carry out fill according to hygienic requirement condition and trimmed size, processes the Saussurea involucrate self-micro-emulsion injection.
Embodiment 11:
Saussurea involucrate self-micro-emulsion preparation 1 weight portion with a said method preparation of claim 1～8 do adds blending tank, adds soft capsule matrix 100 weight portions; It is an amount of to add natural flavorant again; By the requirement of soft capsule preparation, remove impurity, antibacterial; Require to carry out fill according to hygienic requirement condition and trimmed size, process the Saussurea involucrate self-micro-emulsion soft capsule prepn.
Embodiment 12:
Claim 1～8 is made Saussurea involucrate self-micro-emulsion preparation 1 weight portion of a said method preparation; Add blending tank, add hard capsule capsule material excipient substrate 500 weight portions, full and uniform mixing; Carry out the preparation of capsule material, choosing grain, granulate by the wet granulation technique requirement; Antibacterial requires to carry out capsule according to hygienic requirement condition and trimmed size and loads, and processes the Saussurea involucrate self-micro-emulsion hard capsule preparation.
Embodiment 13:
Saussurea involucrate self-micro-emulsion system 1 weight portion with a said method preparation of claim 1～8 do adds blending tank, adds microcapsule formulation substrate 500 weight portions; It is an amount of to add natural flavorant again; Full and uniform mixing, remove impurity, antibacterial; Require to carry out the microcapsule preparation by the requirement of microcapsule preparation, hygienic requirement condition and trimmed size, process the Saussurea involucrate self-micro-emulsion microcapsule formulation.
Embodiment 14:
Claim 1～8 is made Saussurea involucrate self-micro-emulsion preparation 1 weight portion of a said method preparation; Add blending tank, add liniment pharmaceutical base 1000 weight portions, full and uniform mixing; Remove impurity; Antibacterial requires to carry out the liniment preparation by the requirement of liniment preparation, hygienic requirement condition and trimmed size, processes the Saussurea involucrate self-micro-emulsion preparation.
Embodiment 15:
Claim 1～8 is made Saussurea involucrate self-micro-emulsion preparation 1 weight portion of a said method preparation; Add blending tank, add lotion preparation substrate 1000 weight portions, full and uniform mixing; Remove impurity; Antibacterial requires to carry out the lotion preparation by lotion preparation requirement, hygienic requirement condition and trimmed size, processes the Saussurea involucrate self-micro-emulsion lotion preparation.
Embodiment 16:
Claim 1～8 is made Saussurea involucrate self-micro-emulsion preparation 1 weight portion of a said method preparation; Add blending tank, add patch preparation substrate 1000 weight portions, full and uniform mixing; Remove impurity; Antibacterial requires to carry out the patch preparation by patch preparation requirement, hygienic requirement condition and trimmed size, processes the Saussurea involucrate self-micro-emulsion patch preparation.
Claims (5)
1. the method for preparing of a Saussurea involucrate self-micro-emulsion preparation is characterized in that mainly may further comprise the steps:
Quantitatively get ethanol, 1, one or more of 2-propylene glycol, ethylene glycol are as co-emulsifier, and by adding Herba Saussureae Involueratae extract 0.1 weight portion in the 100 weight portion co-emulsifier to excessive, 3～45min ultrasonic dissolution gets Herba Saussureae Involueratae solution under 20～50 ℃ of conditions;
With soybean oil, Oleum Ricini, ethyl oleate, isopropyl myristate arbitrarily one or more as oil phase; 1～20 weight portion is got as emulsifying agent with Tween 80 with the arbitrary proportion mixing by the class of department 80; Join in 5～100 weight portion oil phases 1000～8000rpm mixing and stirring;
With said Herba Saussureae Involueratae solution with added the oil phase behind the emulsifying agent by the mixed of 1:10～1:100 and under 1000～8000rpm high-speed stirred evenly be placed in 20～40 ℃ of waters bath with thermostatic control, continue under 100～2500rpm stirring condition, slowly to add distilled water; During first the interpolation, mixed solution presents muddiness, adds to when a certain amount of; The solution becomes clarification forms self-micro emulsion formulation of the present invention, when continuing to add; When obvious light blue opalescence occurring, can stop to add.
2. the method for preparing of Saussurea involucrate self-micro-emulsion preparation according to claim 1 is characterized in that said Herba Saussureae Involueratae extract is at least a of Herba Saussureae Involueratae injection intermediate, Herba Saussureae Involueratae water extract or ethanol extract.
3. the method for preparing of Saussurea involucrate self-micro-emulsion preparation according to claim 1 and 2 is characterized in that described oil phase is any one or two kinds in ethyl oleate or the isopropyl myristate.
4. a Saussurea involucrate self-micro-emulsion preparation is characterized in that producing according to each described method of claim 1～3.
5. Saussurea involucrate self-micro-emulsion preparation according to claim 4 application, it is characterized in that described Saussurea involucrate self-micro-emulsion preparation is applied to and produce in oral liquid, tablet, capsule, injection, lotion, liniment, patch or the electuary.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2009101135363A CN101721444B (en) | 2009-11-19 | 2009-11-19 | Saussurea involucrate self-micro-emulsion, preparation method thereof and application thereof |
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| CN2009101135363A CN101721444B (en) | 2009-11-19 | 2009-11-19 | Saussurea involucrate self-micro-emulsion, preparation method thereof and application thereof |
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| Publication Number | Publication Date |
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| CN101721444A CN101721444A (en) | 2010-06-09 |
| CN101721444B true CN101721444B (en) | 2012-12-26 |
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| CN102349939B (en) * | 2011-10-21 | 2014-07-16 | 新疆维吾尔自治区药物研究所 | Saussurea involucrate extractive microemulsion compound |
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2009
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Non-Patent Citations (3)
| Title |
|---|
| 中华人民共和国卫生部药典委员会.雪莲注射液.《卫生部颁中药标准（成方制剂）第17册》.1998,Z17-254. * |
| 潘国梁等.药用微乳伪三元相图的几种制备方法比较研究.《中国药房》.2006,第17卷(第1期),第21-23页. * |
| 袁海建等.自微乳药物传递系统及其在中药制剂研究中的应用.《中国药房》.2008,第19卷(第6期),第456-459页. * |
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